- Taiho Oncology (Princeton, NJ)
- Associate Director , Regulatory Affairs Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #386 Tuesday, August 20, 2024 Looking for a chance to make ... Join our dynamic and expanding mid-size oncology company in the role of Associate Director , Regulatory Affairs Operations where you will utilize your… more
- Ascendis Pharma (Princeton, NJ)
- …workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling ... Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine… more
- Bristol Myers Squibb (Princeton, NJ)
- …years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ... careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion… more
- Bristol Myers Squibb (Princeton, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director , Biologics will serve as the primary interface… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …assigned and perform the duties outlined below. This role includes mentoring Regulatory Affairs staff, supporting project teams and development partners, and ... will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination products for the product… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Novo Nordisk (Princeton, NJ)
- …Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and maintain positive ... Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo...rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs -...Affairs , Dietary Supplements This position reports to the Director , Regulatory Affairs and is based ... Summit, NJ **Travel %:** <10% **Pay: 84k- 152k** **What you will do** The Senior Associate , Regulatory Affairs is responsible for developing regulatory … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 ... TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …true to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** ... Here, you will be a vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing and Systems (NRWS)… more
- PSEG (South Plainfield, NJ)
- …for internal and external use. This position will also support State Governmental Affairs in developing legislative and regulatory proposals designed to gain ... camaraderie and care for one another you might typically associate with a small business. Our focus on combatting...plan at the time you separate from the Company. Director Level approval and waiver will be required for… more
- Bristol Myers Squibb (Princeton, NJ)
- …MS or commensurate experience preferred **Experience Requirements** Significant experience in regulatory affairs (eg 3-5 years) **Key Competency Requirements** ... careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Global Real World Evidence - Oncology (Hematology) - 2406215377W **Description** Johnson & Johnson Innovative Medicine is recruiting an ... Associate Director , Global Real World Evidence (RWE),...well as cross-functional and regional partners from Global Medical Affairs , Global Market Access, Global Marketing, Global Epidemiology, J&J… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Medical Excellence and Impact - 2406214789W **Description** Johnson and Johnson Family is recruiting an ** Associate Director , ... **Position Overview:** We are seeking a dynamic and forward-thinking Associate Director , Medical Excellence Lead to join...+ Oversee the assessment and evaluation of key medical affairs programs through surveys and other tools. + Facilitate… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …treatment of bipolar depression in adults as monotherapy and as adjunctive therapy. ** Associate Director / Director , Data Management** will oversee and provide ... Provide direction to study team to maximize compliance with regulatory requirements; review and suggest improvements to operating procedures...health related fields or closely related field + For Associate Director : Minimum of 7 years of… more
- Bristol Myers Squibb (Princeton, NJ)
- …partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and integrate one global ... Include : + Conduct risk assessments specific to medical affairs and clinical trial /research activities, utilizing a combination...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of bipolar depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the ... documents, and responses to health authority information requests. The Associate Director / Director of Medical Writing...in a cross-functional setting with the following teams: + Regulatory Affairs + Clinical Development + Biostatistics… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations,… more